The packaging of investigational medicinal products affects the patient compliance
Melsungen, November 1, 2016
The quality of trial results depends largely on patient compliance. Patient compliance is affected by predictable and unpredictable factors. One of these predictable factors is packaging. The more user-friendly the labeling of investigational products is, the easier they are to use.
In two surveys conducted by ISPE (International Society for Pharmaceutical Engineering) in 2013 and 2015, subjects of clinical trials were questioned about their experiences when using IMPs (investigational medicinal products). Patients’ opinions about the overall ease of use were positive in the US (77%), in the EU (85%) and in China (88%).
Patients’ preference increase for having IMPs delivered directly to their homes. For site personnel, briefing patients on the phone means an effort as opposed to dosing instructions that can be read on the packaging. In addition, all the relevant information is directly and durably attached to the medication.
To reproduce all the necessary information in a reader-friendly font size booklet labels are often used for the purpose of multilingual IMP identification. “The need for comprehensive information is growing. Booklet labels take care of this but ease of use would still appear to need improving”, Anthony Morrow, Business Development Manager Northern Europe at Faubel explains.
This is why Anthony Morrow is in favour of adding clearly visible opening arrows as well as partly rough or rubberized surfaces to booklet labels. Such visual and tactile features draw attention. Moreover, these special surfaces give users a good grip – especially with IMP bottles.
“The specific design of the easy-peel opening section helps when separating the layers of the label. That’s what makes it very easy to open”, says Morrow. Once the label is open, there can be a thumb index to facilitate navigation through the booklet. Patients can get to their national language in just one move. Pictograms or QR codes linked to instructions for use videos are to be regarded as text supplements.
Thanks to these technological advancements, patient’s needs are taking center stage for Anthony Morrow. “Within the clinical trial supply chain, booklet labels do not only allow efficient distribution and safe identification worldwide, but they can also be combined with any measure designed to maximize ease of use in a single product.”